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Actionable news in GILD: Gilead Sciences, Inc.,

Gilead receives approval in Canada for EPCLUSA™ (sofosbuvir/velpatasvir), the first once-daily pan-genotypic (genotypes 1-6) single tablet regimen for the treatment of chronic hepatitis C

-- 12-Week Treatment with EPCLUSA Provides High Cure Rates (SVR12)
For All Six Hepatitis C Genotypes --

MISSISSAUGA, ON, July 14, 2016 /CNW/ - Gilead Sciences Canada, Inc. (Gilead Canada) has received a Notice of Compliance (NOC) from Health Canada for EPCLUSA (sofosbuvir 400 mg/velpatasvir 100 mg), the first once-daily, pan-genotypic single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. EPCLUSA - for 12 weeks - is for use in patients without cirrhosis or with compensated cirrhosis, and in combination with ribavirin (RBV) for patients with decompensated cirrhosis. EPCLUSA is the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for RBV. Health Canada had previously granted EPCLUSA a Priority Review, which is given to a medication that offers a significant advance in treatment over existing options for a serious, life-threatening or severely debilitating condition.

"This newly-approved treatment represents an important step forward in how we treat HCV," said Dr. Jordan Feld, Hepatologist and Research Director, Francis Family Liver Clinic, Toronto Centre for Liver Disease, Toronto General Hospital. "We can now cure the majority of HCV-infected patients with a simple, safe and effective 12-week treatment, regardless of genotype or treatment history."

The approval of EPCLUSA is supported by data from four international Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035 patients with genotype 1-6 chronic HCV infection, without cirrhosis or with compensated cirrhosis (Child-Pugh A) received 12 weeks of EPCLUSA. The ASTRAL-4 study randomized 267 patients with genotype 1-6 chronic HCV infection, with decompensated cirrhosis (Child-Pugh B) to receive 12 weeks of EPCLUSA with or without RBV or 24 weeks of EPCLUSA. The primary endpoint for each study was sustained virologic response 12 weeks after completing therapy (SVR12).

Of the 1,035 patients treated with...